Sr. 供应商质量管理SQE（医疗）
Core
Lead supplier quality system building and continuous improvement for medical injection molding and finished product suppliers to ensure product quality and compliance.
Role type
Senior Supplier Quality Engineer (Medical Devices)
Builds
Medical device components and finished products
Domain
Medical devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier quality management, ISO 13485 compliance, supplier auditing, process validation, non-conformance management, incoming inspection management, risk control
Preferred skills
Injection molding experience, finished product assembly experience, FDA 21 CFR Part 820 QMSR knowledge, Chinese GMP knowledge, quality tools (RCA, SPC, QCP)
Technologies
ISO 13485, FDA 21 CFR Part 820 QMSR, Chinese GMP, RCA, SPC, QCP
Responsibilities
Manage and optimize quality for medical injection molding and finished product suppliers; Ensure supplier compliance with ISO 13485 and regulations; Lead supplier audits (process, system, compliance); Drive mold supplier process validation consistency; Manage supplier non-conformances, SCARs, changes, and risks; Oversee incoming inspection; Support customer audits and regulatory inspections
Seniority
Senior, hands-on IC